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CMS Delays Sunshine Act Data Collection Until January 2013
May 4, 2012By Alan M. Kirschenbaum –
On May 3, 2012, CMS posted on its website a notice announcing that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before January 1, 2013. As we have reported in earlier posts, the sunshine provisions, among other things, require manufacturers of drugs, devices, biologicals, and medical supplies that are covered under Medicare, Medicaid, or the Children’s Health Insurance Program ("CHIP") to report annually to CMS certain payments or other transfers of value to physicians and teaching hospitals. Although the statute requires the first report to be submitted by March 31, 2013 for payments made in calendar year 2012, CMS has long exceeded its statutory deadline of October 1, 2011 for issuing implementing procedures. CMS published a proposed rule last December (see our summary here), and will not be issuing a final rule until “later this year.” According to the notice, the postponement of required data collection will give CMS an opportunity to address over 300 comments submitted on the proposed rule, and will give applicable manufacturers additional time to prepare for transparency report submission. In view of the postponement of data collection, it appears likely that the March 31, 2013 deadline for the first transparency reports will also be extended.
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- FTC Continues to Rage Against Device Patent Listings in the Orange Book March 27, 2024
- FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts March 26, 2024
- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of Directors March 20, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized